PREGABALIN
Specification
Tests
Specifications
Results
Appearance
White to off-white crystalline powder
Complies
Specific Rotation
+10°~+13°
+10.2°
Identification
IR: similar to Reference Substance
Complies
Loss on drying
≤0.5%
0.11%
Chloride
≤0.1%
Complies
Residue on ignition
≤0.1%
0.03%
Solvent residue
Ethyl acetate≤5000ppm
Undetected
Isopropyl alcohol≤5000ppm
980ppm
Tetrahydrofuran≤720ppm
Undetected
Isopropyl ether≤1000ppm
Undetected
Ethanol≤5000ppm
Undetected
Heavy metals
≤0.001%
Complies
Enantiomer
≤0.15%
Undetected
Related substance
CI-4≤0.15%
Undetected
Mandelic Acid≤0.10%
Undetected
CI-6≤0.15%
Undetected
CI-Lactam≤0.15%
Undetected
Unknow impurity≤0.10%
0.09%
Total impurities≤0.8%
0.34%
Assay
98.0%~102.0%
98.9%
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